BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB ROBERTSHAW LEFT 39F

    MDR report key: 3921488 · Received June 6, 2014

    Report

    Report Number
    8040412-2014-00140
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE WAS FOUND BROKEN WHEN INSERTED INTO THE PATIENT. NO REPORTED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331627 RUSCH EB ROBERTSHAW LEFT 39F ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1